APPLICATION
ANDA089776
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-13
LATEST ACTION
2025-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LANIAZIDDiscontinued
ISONIAZID 300MG · TABLET · ORAL
Approval history
2025-02-05Labeling · Supplement 29 · standardAP
2025-01-30Labeling · Supplement 23 · standardAP
2001-11-21Manufacturing (CMC) · Supplement 19AP
2001-11-21Manufacturing (CMC) · Supplement 17AP
2001-11-21Labeling · Supplement 18AP
2001-11-21Manufacturing (CMC) · Supplement 16AP
2001-07-23Manufacturing (CMC) · Supplement 15AP
1997-05-14Labeling · Supplement 14AP
1996-12-11Manufacturing (CMC) · Supplement 13AP
1996-12-11Manufacturing (CMC) · Supplement 8AP
1996-12-11Manufacturing (CMC) · Supplement 11AP
1996-12-11Manufacturing (CMC) · Supplement 9AP
1996-12-11Labeling · Supplement 12AP
1996-12-11Manufacturing (CMC) · Supplement 10AP
1990-01-09Labeling · Supplement 1AP
1988-06-13OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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